Visualisation of the microcirculation of the nasal mucosa in vivo in different nasal disorders, using sidestream dark-field imaging

ISRCTN ISRCTN67264420
DOI https://doi.org/10.1186/ISRCTN67264420
Secondary identifying numbers NTR719
Submission date
21/07/2006
Registration date
21/07/2006
Last edited
05/11/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof W J Fokkens
Scientific

Academic Medical Centre (AMC)
Department of Otorhinolaryngology, Room A2-234
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone +31 (0)20 566 3789
Email W.J.Fokkens@amc.nl

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymViMiNa
Study objectivesXylometazoline nasal spray relieves vasoconstriction in the nasal mucosa, which will be assessed and visualised using sidestream dark-field (SDF) imaging.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNasal disorder
InterventionThe microcirculation of the nasal mucosa of healthy controls will be assessed using a non-invasive probe, diameter 0.5 cm, which will be placed in the nasal cavity, twice for a period of approximately 10 minutes. Images will be recorded to make off-line analysis possible. In between the two periods of recording or measuring, the healthy volunteers will get a provocation with xylometazoline nasal spray or placebo. After a few minutes, a second measurement will be taken to assess possible differences in the microcirculation.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Xylometazoline
Primary outcome measureThe following parameters will be used to assess the microcirculatory reaction after provocation:
Flow in the capillary, venules and arterioles can be scored semi-quantitatively or quantitatively:
1. Semi-quantitative scoring:
0 = no flow
1 = intermittent flow
2 = sluggish flow
3 = continuous flow
2. Quantitative scoring: velocity, flow, diameter, length, density
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/07/2006
Completion date01/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20
Key inclusion criteria1. Patients with active allergic rhinitis, idiopathic rhinitis, chronic rhinosinusitis or nasal polyps
2. Males or females aged over 18 years; no maximum age
3. Approval from the patient's physician
4. Written informed consent
Key exclusion criteria1. Smoker
2. Severe cardiac or pulmonary disorder
3. Peripheral vascular disease
4. Medication: systemic alpha-blockers, corticosteroids (local and systemic), any local nasal treatment, bronchodilatory inhalation medication for pulmonary diseases >1000 µg/day
5. Cystic fibrosis, immotile cilia syndrome, Rendu-Osler-Weber disease, vasculitis
6. Cocaine and/or alcohol abuse
Date of first enrolment01/07/2006
Date of final enrolment01/12/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre

Department of Otorhinolaryngology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website http://www.amc.uva.nl
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Centre (AMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan